NCT00900523

Brief Summary

RATIONALE: Measuring the amount of prostaglandin metabolite in urine samples and studying tissue samples in the laboratory from patients with ovarian cancer may help doctors identify and learn more about biomarkers related to ovarian cancer and may help the study of cancer in the future. PURPOSE: This laboratory study is measuring the amount of prostaglandin metabolite in urine samples from patients with ovarian cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

May 9, 2009

Last Update Submit

April 17, 2013

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancerstage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

  • Prostaglandin E2 metabolite (PGE-M) levels in 24-hour urine samples

    Patients will be collect their urine for 24 hours before they undergo any surgery or chemotherapy. Researchers will measure the amount of PGE-M in the urine.

    Pre-surgical or chemotherapeutic treatment, over a 24-hour duration

Secondary Outcomes (2)

  • COX-1 and COX-2 expression in ovarian tumor tissue and non-malignant tissue

    Day of surgery

  • Correlation of urine PGE-M levels with tissue COX-1 and COX-2 levels

    After patients' surgery

Study Arms (1)

Known or suspected ovarian cancer

Women who have a diagnosis of ovarian cancer or who are suspected of having ovarian cancer

Genetic: protein expression analysisOther: immunohistochemistry

Interventions

protein expression analysisGENETIC

protein expression analysis

Also known as: protein expression analysis for PGE-M
Known or suspected ovarian cancer
immunohistochemistryOTHER

immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels

Also known as: immunohistochemistry staining methods
Known or suspected ovarian cancer

Eligibility Criteria

Age17 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with known or suspected ovarian cancer who are greater than 17 years in age.

You may qualify if:

  • Diagnosis of known or suspected ovarian cancer
  • Age greater than 17 years

You may not qualify if:

  • Pregnant or nursing
  • Taking steroids or non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis.
  • PRIOR CONCURRENT THERAPY:
  • No concurrent chronic use of steroids or NSAIDs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

7-hydroxy-5,11-dioxotetranorprostane-1,16-dioic acidImmunohistochemistry

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • Marta Crispens, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor; Gynecological Oncologist

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

November 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2008

Last Updated

April 18, 2013

Record last verified: 2013-04